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FDA 510(k)

Dendrite Imaging System

K-Number: K253303 · 2025-11-28

ApplicantDendrite Imaging, Inc.
Decision Date2025-11-28
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dendrite Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Dendrite Imaging, Inc.. It received FDA 510(k) clearance on 2025-11-28 under 510(k) number K253303. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dendrite Imaging System?

Dendrite Imaging System is a medical device that received FDA 510(k) clearance on 2025-11-28. The listed applicant is Dendrite Imaging, Inc.. The 510(k) number is K253303.

When did Dendrite Imaging System receive FDA 510(k) clearance?

Dendrite Imaging System received FDA 510(k) clearance on 2025-11-28, under 510(k) number K253303.

Who is the listed applicant for Dendrite Imaging System?

The FDA 510(k) record lists Dendrite Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dendrite Imaging System?

The FDA product code for Dendrite Imaging System is QDG.

Related Devices (Code: QDG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)K230898FLUOBEAM® LX RedFluoptics SasK190891Fluobeam LXFluoptics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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